Sr Reliability Engineer - Exempt

We are currently seeking a professional to join our Neuromodulation and Pelvic Health team to drive and support risk management sustaining activities. This role is based in Minneapolis, MN, a vibrant city known for its rich cultural scene and diverse community. Enjoy the benefit of working remotely on Fridays while being part of an innovative team. Responsibilities Maintain a thorough knowledge and understanding of ISO 14971 and risk management practices, such as Hazard Analysis and Failure Mode and Effects Analysis. Collaborate with cross-functional teams (including Design, Human Factors, Medical Safety, Reliability, and Post-Market Quality) to ensure that all hazards associated with medical devices are identified, the associated risks are estimated, evaluated, and that product/system performance is quantifiably predicted. Work with project teams to ensure that risk controls are identified and properly implemented, verified, and validated. Evaluate the impact of potential issues on patient safety and product performance. Perform and document Risk Reviews to communicate the results of the risk management process to the cross-functional teams. Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk Management team members that share in varying pieces of the risk management lifecycle. Identify and act upon opportunities for continuous improvement of the Risk Management Process. Provide input to design/process development, design controls, and design validation for achieving required levels of product safety and performance. Create documentation in compliance with applicable procedures to meet project deliverables. Must Have Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.G., Product Hazard Analysis, Design and Process FMEA, User Analysis). Experience in the application of statistics. Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering. Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA). Experience with implantable medical devices. Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results. Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work. Nice to Have A self-motivated learner who actively seeks out new knowledge, skills, and solutions to adapt to evolving challenges. Experience with data analytics. Qualifications Experience with implantable medical devices. Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.G., Product Hazard Analysis, Design and Process FMEA, User Analysis). Experience with FDA 21 CFR 820, ISO 13485, European Union (EU) Medical Device Regulation (MDR), and State of the Art (SOTA). Experience with Design Control Deliverables to include Product Performance Specifications, Design Verification, Design Validation, and Design Transfer, and Usability and Human Factor Engineering. Experience in the application of statistics. Strong attention to detail with the ability to maintain accuracy and thoroughness in all aspects of work. Demonstrated leadership skills with confidence in taking initiative and guiding teams effectively. Highly proactive and able to anticipate needs, identify opportunities, and act independently to drive results.

Created: 2026-04-02